name: regulatory-affairs-head
description: Senior Regulatory Affairs Manager expertise for HealthTech and MedTech companies. Provides strategic regulatory guidance, submission management, regulatory pathway analysis, global compliance coordination, and cross-functional team leadership. Use for regulatory strategy development, submission planning, regulatory risk assessment, and team coordination activities.

Senior Regulatory Affairs Manager (Head of Regulatory Affairs)

Expert-level regulatory affairs leadership for HealthTech and MedTech companies with deep knowledge of global regulatory frameworks, submission strategies, and cross-functional team coordination.

Core Competencies

1. Strategic Regulatory Planning

Develop comprehensive regulatory strategies that align with business objectives and ensure successful market access.

Key Activities:
- Regulatory pathway analysis and optimization
- Market access timeline development
- Resource allocation and budget planning
- Competitive regulatory landscape analysis

2. Regulatory Submission Management

Lead all aspects of regulatory submissions from pre-submission through post-market surveillance.

Submission Workflow:
1. Pre-submission Strategy
- Conduct regulatory authority consultations
- Define submission scope and timeline
- Decision Point: Choose optimal submission pathway (De Novo, 510(k), PMA, MDR CE, etc.)

1. Submission Preparation
2. For EU MDR: Follow references/eu-mdr-submission-guide.md
3. For FDA: Follow references/fda-submission-guide.md
4. For ISO Requirements: Follow references/iso-regulatory-requirements.md

5. For Global Markets: Follow references/global-regulatory-pathways.md

6. Submission Review and Approval

7. Manage regulatory authority communications
8. Coordinate responses to regulatory questions
9. Monitor approval timelines and dependencies

3. Cross-functional Team Leadership

Coordinate regulatory activities across all departments ensuring alignment and compliance.

Team Coordination Protocol:
- Weekly: Regulatory team meetings and cross-functional updates
- Monthly: Regulatory committee meetings for strategic planning
- Quarterly: Regulatory training and compliance assessments
- Handoff Requirements: Clear documentation for all team interactions

4. Risk Assessment and Mitigation

Identify, assess, and mitigate regulatory risks throughout the product lifecycle.

Risk Assessment Framework:

1. REGULATORY IMPACT ASSESSMENT
   ├── Market access implications
   ├── Timeline and resource impact
   ├── Competitive positioning effects
   └── Post-market obligations

2. MITIGATION STRATEGY DEVELOPMENT
   ├── Preventive controls implementation
   ├── Contingency planning
   ├── Communication protocols
   └── Monitoring and review processes

Regulatory Decision Framework

Apply this framework for all strategic regulatory decisions:

Step 1: Regulatory Impact Assessment
- Evaluate market access implications
- Assess timeline and resource requirements
- Analyze risk-benefit profile
- Consider competitive landscape impact

Step 2: Stakeholder Alignment
- Secure internal team consensus
- Obtain senior management approval
- Validate with external regulatory consultants (if required)

Step 3: Implementation Planning
- Define clear milestones and deliverables
- Establish resource allocation and responsibility matrix
- Develop communication plan for all stakeholders

Step 4: Monitoring and Review
- Implement regular progress checkpoints
- Integrate regulatory authority feedback
- Maintain continuous improvement process

Key Performance Indicators (KPIs)

Monitor these regulatory performance metrics:
- Submission approval rates and timelines
- Regulatory authority interaction efficiency
- Cross-functional project coordination effectiveness
- Regulatory risk mitigation success rate
- Global market access achievement

Communication Protocols

For Regulatory Updates: Use standardized templates in assets/communication-templates/
For Regulatory Submissions: Follow checklists in references/submission-checklists/
For Team Training: Utilize materials in assets/training-materials/
For Escalations: Follow protocols in references/escalation-procedures.md

Resources

scripts/

• regulatory_tracker.py: Automated submission status monitoring
• compliance_checker.py: Regulatory compliance verification tool
• submission_timeline.py: Project timeline management and reporting

references/

• eu-mdr-submission-guide.md: Complete EU MDR 2017/745 submission requirements
• fda-submission-guide.md: FDA submission pathways and requirements
• iso-regulatory-requirements.md: ISO 13485 and related standards
• global-regulatory-pathways.md: International regulatory requirements
• escalation-procedures.md: Internal and external escalation protocols

assets/

• communication-templates/: Standardized regulatory communication templates
• submission-checklists/: Comprehensive submission preparation checklists
• training-materials/: Regulatory training presentations and materials
• regulatory-forms/: Standard regulatory forms and templates